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Details for Generic Name: regadenoson

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Regadenoson is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-six patent family members in twenty-four countries.

There are two drug master file entries for regadenoson. One supplier is listed for this compound.

Summary for Generic Name: regadenoson

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers: see list1

Pharmacology for Ingredient: regadenoson

Clinical Trials for: regadenoson

Regadenoson to Achieve Maximal Hyperemia for Fractional Flow Reserve in the Catheterization Lab
Status: Recruiting Condition: Coronary Artery Disease

Regadenoson and Adenosine
Status: Completed Condition: Coronary Artery Disease

Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)
Status: Completed Condition: Coronary Artery Disease; Type 1 Diabetes Mellitus

Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Status: Recruiting Condition: Myocardial Blood Flow Reserve

Regadenoson Real Time Perfusion Imaging Trial-Optison
Status: Recruiting Condition: Coronary Artery Disease; Myocardial Perfusion Abnormalities

Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson
Status: Completed Condition: Ischemic Heart Disease

A Phase II Trial of Regadenoson in Sickle Cell Anemia
Status: Recruiting Condition: Sickle Cell Anemia

Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress
Status: Completed Condition: Coronary Artery Disease

ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Status: Completed Condition: Coronary Artery Disease

ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Status: Completed Condition: Coronary Artery Disease

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes8,470,801<disabled><disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes8,183,226<disabled><disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes8,106,183<disabled>Y<disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes7,183,264<disabled>Y<disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes6,642,210<disabled>YY<disabled>
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Non-Orange Book Patents for Generic Ingredient: regadenoson

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,524,883Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide<disabled in preview>
8,268,988Process for preparing an A2A-adenosine receptor agonist and its polymorphs<disabled in preview>
7,732,595Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs<disabled in preview>
8,569,260N-pyrazole A.sub.2A receptor agonists<disabled in preview>
8,906,878Myocardial perfusion imaging methods and compositions<disabled in preview>
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International Patent Family for Ingredient: regadenoson

Country Document Number Publication Date
China1671399Sep 21, 2005
Mexico2007004749Jun 18, 2007
New Zealand570239Sep 30, 2011
Canada2439222Aug 30, 2001
Canada2377746Dec 28, 2000
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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